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TerminatedNCT02218879Updated Sep 5, 2016

Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS

An observational study in Multiple Sclerosis, sponsored by Yale University. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-09-05.

Sponsored by Yale University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The primary objective is to directly estimate brain glutathione concentrations in vivo using H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS) patients considering switching therapy or being treatment-naive (first line).

02

Conditions studied

  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 7 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a relapsing form of MS

Inclusion criteria

  • Male or female adult patients
  • 18-60 years of age
  • Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
  • Patients naive to MS therapy or patients switching from an FDA-approved MS therapy, including IFN-B formulations, Cop-1, Teriflunomide, and Fingolimod to BG-12
  • Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion criteria

Exclusion Criteria:

  • Primary progressive multiple sclerosis patients
  • Patients with previous exposure or known allergies to fumarates
  • MS patients switching from natalizumab, cyclophosphamide, or mitoxantrone to BG-12
  • Contraindications for MRI/MRS
  • Known presence of other neurological disorders that may mimic multiple sclerosis
  • Pregnancy or lactation
  • Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of or currently active primary or secondary immunodeficiency
  • Active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis B or C, HIV, syphilis, tuberculosis_
  • History of progressive multifocal leukoencephalopathy
  • Contraindications to or intolerance of oral or intravenous (IV) corticosteroids
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with relapsing MS

    Drug: Tecfidera

Interventions

  • DrugTecfidera

    Oral Tecfidera 240 mg bid

06

What researchers measure

Primary outcomes

  1. Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan

    Time frame: Before and 12 months after Tecfidera Initiation

07

Study locations

1 site
  • Yale University
    New Haven, Connecticut 06519, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02218879
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Aug 18, 2014
Start date
Aug 2014
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Sep 5, 2016

Study contacts

Daniel Pelletier, MD
principal investigator · Yale University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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